Global SWIFT studies will evaluate safety and efficacy of CSL Behring’s Biostate(R) for von willebrand disease and hemophilia-A.
A global trial to develop Biostate announced at the 3rd Annual Congress of the European Association of Haemophilia and Allied Disorders.
CSL Behring announced today the start of the global clinical trial program SWIFT (Studies with von Willebrand factor [VWF]/Factor VIII) to evaluate the pharmacokinetics, efficacy and safety of Biostate(R), a low-volume, highly active, plasma-derived VWF/FVIII concentrate for the treatment of von Willebrand disease (VWD) and hemophilia A. The methodology behind the multi-center trials was detailed in a presentation at the 3rd Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD) today.
“The management of patients with bleeding disorders like VWD and hemophilia A continues to be challenging, and we welcome new therapeutic options,” said Professor Toshko Lissitchkov, M.D. of Specialized Haematological Hospital Joan Pavel. “Our goal with the SWIFT program is to evaluate the safety and efficacy of Biostate, a factor concentrate with high specific activity that has the potential to benefit patients.”
The SWIFT program, which will include centers in Europe, North America and South America, comprises four open-label studies in adults/adolescents and children with VWD and hemophilia A. CSL Behring is performing the SWIFT studies to meet the regulatory requirements for making Biostate available in multiple countries. Biostate has been available in Australia since 2003 where it is indicated for the treatment of von Willebrand disease hemophilia A.
“CSL Behring has a heritage of innovation in developing bleeding disorder therapies and making a difference in patients’ lives,” said Russell Basser, M.D., Senior Vice President, Global Clinical Research, CSL Behring.
“CSL Behring’s commitment to the hemophilia and von Willebrand disease community will be further strengthened by Biostate’s development and approval. It will provide physicians and patients with another option in the management of bleeding disorders, joining CSL Behring’s Haemate(R) P/Humate-P(R) and other therapies.”